Companion diagnostics (CDx) is a medical device which provides information that is essential for the safe and effective use of a corresponding drug. The test helps health care professionals identify patients who are most likely to benefit from a particular therapeutic product and patients who are likely to be at increased risk for serious side effects as a result of treatment.
Companion diagnostics can also be used to monitor patient response to treatment for the purpose of adjusting treatment to achieve improved safety or effectiveness.
EndoPredict® is a prognostic 2nd generation IVD gene expression test to determine the risk of distant metastases in patients with estrogen receptor positive, HER2-negative primary breast cancer.
myChoice® CDx is the most comprehensive tumor test that determines HRD status in patients with ovarian cancer. This FDA-approved test helps provide information on the magnitude of benefit for PARP inhibitor therapy.